Clinical study of medical devices for quantifying and/or classifying motor deficits in patients with Parkinson’s disease or essential tremor - Clinical study for ANLIVA™ Dyskinesia & ANLIVA™ Eye Movement

ISRCTN	ISRCTN82413223
DOI	https://doi.org/10.1186/ISRCTN82413223
Secondary identifying numbers	DOC-303

Submission date: 01/12/2023
Registration date: 14/12/2023
Last edited: 28/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to see if medical devices can be used for quantifying and/or classifying motor deficits in patients with Parkinson’s disease and essential tremor.

Who can participate?
Patients diagnosed with Parkinson’s disease or essential tremor and healthy control volunteer control subjects aged between 18 and 80 years old

What does the study involve?
The study involves measurements/data acquisition of motor deficits with a smartphone of ocular movements by using an advanced tracking camera device in combination with a computer.

What are the possible benefits and risks of participating?
The possible benefits include making an objective quantification and/or classification of tremor/hyperkinesia and an objective quantification of ocular movements.

The methods used in the study do not use any physical interventions, but the eye-tracking camera could be perceived as an intrusion of privacy.

Where is the study run from?
Uppsala University Hospital and Sahlgrenska University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
August 2022 to October 2023

Who is funding the study?
1. VINNOVA Swedish Governmental Agency for Innovation Systems (Sweden)
2. Stardots AB (Sweden)

Who is the main contact?
Martin Nilsson (Stardots AB), martin.nilsson@stardots.se (Sweden)

Contact information

Dr Martin Nilsson
Public, Scientific

Kungsangsvagen 31A
Uppsala
SE-753 23
Sweden

Phone	+46(0)707799295
Email	martin.nilsson@stardots.se

Prof Dag Nyholm
Principal Investigator

Akademiska sjukhuset
Uppsala
SE 751 85
Sweden

Phone	+46(0)18-611 00 00
Email	dag.nyholm@neuro.uu.se

Prof Filip Bergquist
Principal Investigator

Sahlgrenska Academy
University of Gothenburg
Gothenburg
SE-413 45
Sweden

Phone	+46(0)31-342 10 00
Email	filip.bergquist@pharm.gu.se

Study information

Study design	Double-center open-label controlled exploratory pilot stage study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Other, Safety
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Patients with tremor or hyperkinesia or with ocular motor deficits such as e.g. patients with Parkinson's disease or essential tremor. Measurement/ quantification of tremor or hyperkinesia using the mobile sensors of a Smartphone or of eye movements by using an advanced tracking camera device in combination with a computer No comparator Complications/adverse events and statistics of such; Correlation and accuracy of quantification of tremor or hyperkinesia or correlation and accuracy of the eye movements.
Study objectives	Is it possible to use medical devices ANLIVA™ Dyskinesia and/or ANLIVA™ Eye Movement to quantify and/or classify motor deficits in patients with Parkinson’s disease or essential tremor?
Ethics approval(s)	Approved 20/02/2023, Gothenburg Department 1 Medicine (Box 2110, Uppsala, SE-75002, Sweden; +46(0)10-4750800; registrator@etikprovning.se), ref: CIV-ID 22-11-041486
Health condition(s) or problem(s) studied	Parkinson's disease and essential tremor
Intervention	This exploratory pilot study aims to assess mathematical algorithms' performance using smartphone sensor data and eye tracking in individuals with Parkinson’s disease and essential tremor. The study involves using a medical device that will not impact participants physically. Data collected from the device will be compared to assessments conducted by a qualified medical professional (Neurologist) to evaluate the accuracy and reliability of the algorithms in measuring and correlating relevant data. The subjects participate in one visit, which takes less than one hour per visit. The sessions are held at healthcare institutions and neurological clinics at two university hospitals. The participants are asked in advance if they are willing to participate with a description of what is needed, they then book a date for when to visit the clinic, visit the clinic and sign the informed consent. They are given the info from the Patient Information Sheet and will do the following tests: i) move a mobile phone from table to ear and back to table position 3 times with each hand; ii) sit down in front of a computer and look at moving dot on the computer screen and an advanced camera records the eye movements; and, iii) have an assessment of their status by health care personnel. No intervention is done, i.e. no change in any medication nor anything else that changes the medical state the subject is in. The test with a mobile phone takes less than a minute. The test when looking at a computer screen takes 2 minutes. ANLIVA™ Dyskinesia measures movement disturbances from a “perfect” trajectory and uses sensors in the mobile phone (accelerometers, gyroscope etc) to get the deviation. ANLIVA™ Eye Movement measures eye movements, more specifically how the pupil moves when the subject is looking at the moving dot on the screen. It is not easy to say exactly what is measured, but in one way it is the angle difference the camera is detecting or the distance the eye has rotated relative to the face.
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	ANLIVA™ Dyskinesia, ANLIVA™ Eye Movement
Primary outcome measure	1. Movement disorder of hands measured using sensors in a mobile smartphone when the subject moves the mobile phone in a certain pattern, for approx. 1 minute during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Dyskinesia. 2. Movement disorder of eyes measured using an advanced camera when the subject looks at a computer screen and follows how a pattern moves on a computer screen, for approx. 2 minutes during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Eye Movement.
Secondary outcome measures	The following secondary outcome measures are measured using data recorded during the clinic visit: 1. Correlate the result of tremor and hyperkinesia detection with a neurologist assessment 2. Accuracy of classification between ET- and PD-induced tremor or hyperkinesia 3. Receiver Operating Characteristic (ROC) curve analysis 4. Accuracy of classification 5. Receiver Operating Characteristic (ROC) curve analysis
Overall study start date	01/08/2022
Completion date	01/10/2023

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	80
Total final enrolment	52
Key inclusion criteria	1. Patients already diagnosed with PD or ET or Healthy volunteers 2. Able to understand and sign the informed consent.
Key exclusion criteria	1. No signing of the informed consent 2. Below 18 years of age 3. Involvement in the planning and conduct of the clinical investigation (applies to all Stardots management staff, investigational staff and third-party vendors as applicable).
Date of first enrolment	15/03/2023
Date of final enrolment	01/09/2023

Locations

Countries of recruitment

Sweden

Study participating centres

Uppsala University Hospital, Uppsala, Sweden

Akademiska sjukhuset, Uppsala
Uppsala
75185
Sweden

Sahlgrenska University Hospital, Gothenburg, Sweden

Sahlgrenska Universitetssjukhuset, Göteborg.
Gothenburg
41345
Sweden

Sponsor information

Stardots AB
Industry

Kungsangsvagen 31A
Uppsala
SE-753 23
Sweden

Phone	+46 (0)707-827001
Email	daniel.petrini@stardots.se
Website	https://stardots.se/

Funders

Funder type

Industry

Stardots AB

No information available

VINNOVA
Government organisation / National government

Alternative name(s): Swedish Governmental Agency for Innovation Systems
Location: Sweden

Results and Publications

Intention to publish date	31/03/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Martin Nilsson (Stardots AB), martin.nilsson@stardots.se (Sweden). Data will be shared data with principal investigators. Investigators may share participant data with participants as the sponsor is unaware of who the participants are.

Editorial Notes

28/10/2024: The intention to publish date was changed from 15/10/2024 to 31/03/2025. Total final enrolment added.
04/12/2023: Study's existence confirmed by the Swedish Ethical Review Authority, Gothenburg Department 1 Medicine (Sweden).